Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Batch/Lot Information

Details about batches of the drug product and substance, with identifiers.

Product

Resources

Medicinal Product Definition	The drug product (Stelbat tablets, 20mg)
Medication	Identifying information about the actual batches of the product (instances)

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.5 Control of Drug Product
  • 3.2.P.5.4 Batch Analyses

XML and JSON examples of synthetic quality data:

• Product Batch or Lot information example XML
• Product Batch or Lot information example JSON

HTML rendering of synthetic quality data:

• Drug Product Batch or Lot Information - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

Substance

Resources

SubstanceDefinition	The substance itself
Substance	Identifying information about the actual batches of the substance (instances)

Examples

CTD section synthetic source data samples (PDF):

• 3.2.S.4 Control of Drug Substance
  • 3.2.S.4.4 Batch Analyses

XML and JSON examples of synthetic quality data:

• Substance Batch or Lot information example XML
• Substance Batch or Lot information example JSON

HTML rendering of synthetic quality data:

• Drug Substance Batch or Lot Information - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

Profiles

See Artifacts Index: Domain Bundle Profiles